Gynecological ImagingUltra-BankNCT07031921
Ultrasound Image Bank: Advancing Medical Research and Diagnostics
An observational study of Gynecological Imaging and Ultrasound Diagnostics, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Imaging, Ultrasound Diagnostics, Gynecologic Disease
- How many people
- 25,000 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jun 2025to 30 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who come to undergo an ultrasound examination at the Class Ultrasound OMIC Center fulfilling the inclusion criteria.
Who may be able to join
- All patients examined at Class Ultrasound OMIC of Fondazione Policlinico Gemelli, IRCCS in Rome.
- All patients can be enrolled regardless the results of ultrasound examination: no evidence of disease, suspicion of benign or malignant pathologies
- Aged ≥ 18 years old
- Patients who were previously enrolled and their outcome has been completed
- Signature of informed consent
Who cannot join
- No signed informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ANTONIA CARLA TESTA, Professor, 0630156399, antoniacarla.testa@policlinicogemelli.it
Antonia Carla Testa, prof
About this study
The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes.
This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.
- Keywords
- Ultrasound Imaging
- Medical subject headings
- Genital Diseases, Female
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a digital ultrasound image biobank including follow-up data
Systematic prospective collection and storage of 2D ultrasound images and video clips from patients undergoing gynecological ultrasound examinations. Each record will be associated with follow-up data, including histological results (within 3 months post-surgery, if applicable) and/or ultrasound re-evaluation (at 1-year follow-up). The goal is to generate a comprehensive image biobank for future research, including artificial intelligence studies.
Measured: Up to 12 months after initial ultrasound examination (including follow-up data)
Secondary outcomes (1)
Percentage of enrolled patients with complete follow-up data (histological results or 1-year ultrasound)
Proportion of patients for whom follow-up data are available, defined as histological examination results within 3 months for those undergoing surgery, or ultrasound follow-up findings at 1 year for those not undergoing surgery.
Measured: Up to 12 months after initial ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start25 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological ImagingStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Carla Testa, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031921
- Sponsor's protocol ID
- 7692
- Acronym
- Ultra-Bank
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Image Bank: Advancing Medical Research and Diagnostics
- ClinicalTrials.gov ID
- NCT07031921
- Acronym / sponsor ID
- Ultra-Bank / 7692
- Keywords
- Ultrasound Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study titled "Ultrasound Image Bank: Advancing Medical Research and Diagnostics", sponsored by the Fondazione Policlinico Universitario A. Gemelli IRCCS, aims to create a large-scale database of gynecological ultrasound images. These images will be collected during routine clinical care from both healthy patients and those with benign or malignant gynecological conditions. The goal is to support medical training, clinical research, and the development of artificial intelligence (AI) models for diagnostic purposes.
This is a prospective, observational, single-center study, with an expected enrollment of approximately 25,000 patients over five years. The ultrasound images will be linked to histological outcomes (for those undergoing surgery within 3 months) or to follow-up scans at 1 year, to enhance early diagnosis and personalized treatment approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who come to undergo an ultrasound examination at the Class Ultrasound OMIC Center fulfilling the inclusion criteria.
Key inclusion criteria (5 listed)
- All patients examined at Class Ultrasound OMIC of Fondazione Policlinico Gemelli, IRCCS in Rome.
- All patients can be enrolled regardless the results of ultrasound examination: no evidence of disease, suspicion of benign or malignant pathologies
- Aged ≥ 18 years old
- Patients who were previously enrolled and their outcome has been completed
- Signature of informed consent
Key exclusion criteria (1 listed)
- No signed informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishment of a digital ultrasound image biobank including follow-up data
Time frame: Up to 12 months after initial ultrasound examination (including follow-up data)
Systematic prospective collection and storage of 2D ultrasound images and video clips from patients undergoing gynecological ultrasound examinations. Each record will be associated with follow-up data, including histological results (within 3 months post-surgery, if applicable) and/or ultrasound re-evaluation (at 1-year follow-up). The goal is to generate a comprehensive image biobank for future research, including artificial intelligence studies.
1 secondary outcome
Percentage of enrolled patients with complete follow-up data (histological results or 1-year ultrasound)
Time frame: Up to 12 months after initial ultrasound examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
Related trials for Gynecological Imaging
Not yet recruitingObservational study
Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies
Gynecologic Cancer, Cervical Cancer
Not yet recruiting
[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).
Lobular Carcinoma, Breast Cancer
RecruitingPhase 1
Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
Gynecological Cancers
Not yet recruiting
Investigating the Correlation Between Pre-Treatment Imaging-Derived Body Composition, Chemotherapy Dose Adjustment, and Treatment Efficacy in Gynecological Cancer Patients "
Search MeSH
RecruitingObservational study
High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonia Carla Testa principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecological Imaging and Ultrasound Diagnostics, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia Carla Testa (0630156399, antoniacarla.testa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a digital ultrasound image biobank including follow-up data (time frame: Up to 12 months after initial ultrasound examination (including follow-up data)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.